Moberg Pharma AB (publ)

Hello everyone and thank you for joining the Moberg Pharma Q3 Earnings Call. My name is Becky and I will be your operator today. During the presentation, you can register a question by pressing star followed by one on your keypad. If you change your mind, please press star followed by two. I will now hand over to your host, CEO of Moberg Pharma, Anna Young, to begin. Please go ahead.

Thank you and good afternoon everyone. Thank you for joining our Q3 earnings call today. I'm Anna Jung, CEO of Mobut Pharma, and I also have our VP of Finance, Mark Beveridge, with me today. We're happy to present our Q3 report that you can find on our webpage. There you can also find a PowerPoint presentation that I'll base this call upon. And this call will be recorded and uploaded to our webpage. In today's call, I'll be providing an overview of our performance this quarter, discussing key developments in our business, and highlighting important strategic milestones. Starting with the positive developments, I'm proud to report that Teclara continues to lead the market in Sweden. The launch has exceeded our expectations, making a strong and successful market entry that has established our presence effectively. Year-to-date, we captured 30% of the market share by value and 25% by units in pharmacy sales to end consumers. Teclara became first available in stores in February this year. with the bulk of initial resets appearing on the shelves from March. Looking at the period from the first full month of sales, in April, to the end of this quarter, Petlara reached a market share of 37% in value and 31% in units in pharmacy sales to consumers. For Q2 specifically, those figures amounted to 34% by value and 78% by units. Our distribution network has expanded. with its Terclara now available in more than 90% of Swedish pharmacies and represented in every major pharmacy chain. This broad accessibility has been tied also in Dragon Category Growth, which rose by an impressive 41% during this third quarter. The reception from the market has been remarkable. We were honored to have Terclara recognized as the best launch of the year by Cronos Apothec and DOS Apothec. Additionally, our partner Algarma received an honorable mention from Apotheke Desta for their contributions as a healthcare provider. We could not have wished for a better launch. We have also managed to overcome initial distribution challenges. Initially, one major pharmacy chain chose not to stock Perklara. However, due to the strong patient demand, 45 of the chain's pharmacies ordered the product through independent wholesalers. This results in the chain formally including Terchara into its lineup, highlighting the significant interest and trust from consumers. This high demand has also led us to speed up our production schedule. We successfully brought forward our next-gen production, delivered in August, which helped maintain stock levels for distribution. However, due to lead times in manufacturing and booking of advertising campaigns, our Q3 market share did see some temporary adjustments compared to Q2. To mitigate the risk of out-of-stock situations, we reduced marketing efforts, but were pleased to see sales recover healthily by the end of the quarter. Ensuring supply of our active ingredient, Turbinafin, to enable further launches remained a priority. We have secured enough Turbinafin to meet current needs for the switch market until we transition to a new supplier. We continue to work according to plan on our two parallel tracks to ensure a stable supply of Turbinafin. with the goal of getting at least one turbinatin supplier approved in the near term. We have answered questions from the Swedish MPA regarding this application and are now awaiting the agency's decision regarding supplier approval. Turning now to the U.S. market and our ongoing phase 3 clinical study that nears completion, we received blinded data from a subset of patients indicating that the clinical QRA might be low our initial expectations. This insight has led us to adjust our outlook for the study's primary endpoint and considered the increased risk of not achieving U.S. commercialization based on this trial alone. For approval in the U.S., the FDA normally requires two studies showing superiority. We already have one such study in place, and the current trial was designed to provide a second study and potentially enhance our dossier with a modified dosing regimen. It would be a major competitive advantage for our patients, so on to only need weekly treatments after the initial phase. Our priority is to protect the date-linked geography of the study, both to preserve the ability to use the study results in discussions with regulatory authorities, and because there are patients currently ongoing treatment in the study. We anticipate announcing the top-line results in December, with further analysis expected to continue thereafter, and only then we will be able to fully assess the situation. We work with leading experts in the field to analyze and understand data as it becomes available. Regarding our European commercial assets, it's crucial to emphasize that in EU, we have an approved product that has a different dosing. This approved product works as documented in previous clinical trials. Even for the markets where we have partners outside of Europe and are preparing the registration file, the local registration file refers to the European dossier. We have approvals in 13 EU countries. and remain on track for our launch with approval countries in 2026, leveraging the strong foundation made by our Swedish success. We have five strong partners in place, including Barrier for Europe and Cypher in Canada. Alderma has once again proven to be an excellent partner in Sweden. Their leadership, marked by previous successes with Nalox in the Nordics, has been a key factor in our positive results. Our collaboration model with Alderma serves as a blueprint for future launches. The fact that the Swedish launch has been so successful, and that we not only immediately became the market leader, but also grow the total market, is a clear indication that our message truly resonates, where we have shown in two large phase 3 studies that 76% of patients become fungus-free, which is world-leading and better than any topical treatment. Turning to the figures, our revenue for the quarter was $3.9 million, whereas product sales of $2.2 million and a milestone payment of $1.7 million. As the launch started this year, there are no revenue in the comparison period. Post-wise, we are following our projections, and we also have a strengthened cash positioning following the CO2 warrants this summer. Cash at the end of this quarter was $3.09 million. In summary, the strong performance of Treklara in Sweden demonstrates that our strategy is effective, both in terms of product positioning and market experience. The recognition from the industry and positive feedback from consumers validate our approach and underscore our potential for growth in new markets. While we remain cautious with our expectations for the U.S. Phase III results, we are confident that our proactive planning and strategic deliberations position us well for the future. Thank you for your attention. I'll stop here and I'm happy to open up for questions.

Thank you. As a reminder, to ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. I'll pause briefly whilst we wait for questions to come through. Our first question is from . The line is now open. Please go ahead.

Hi, Anna. Thank you for doing this call. My question is regarding the milestone payment from Bayer. Can you elaborate on how much more should we expect in the coming quarters? What are the milestones for? basically, if this was at the end of the quarter or in the beginning of the quarter. Thank you so much.

Yes, so this milestone is a part of a larger process, basically bound by specific targets and criteria set out by our contractual terms with Bayer. And as before, we don't comment on the milestones to come. We have only given the total amount of milestones for each partner, and we will report them when they happen. I will repeat again that the majority of our milestones, and that's true for, I would say, every partner agreement, is sales-related, and then we have some development milestones.

Thank you so much. And the other question that I had, basically, if you could comment on – Don't know if this is already being discussed or not, but a potential OTC route in the U.S. Thank you so much.

Sorry, I didn't quite hear the question. Could you repeat this?

Yes, I was wondering if assuming that, you know, the phase three results don't change much from what unfortunately was already sent or basically the results are not so great, but they are good enough to get an approval, basically it's better than placebo. is there anything that could be done to push for an OTC route in the U.S. with the FDA, given there are no side effects on this product?

Yes. So I think based on this initial data that we received, we're, of course, investigating all possible routes to market, given different scenarios. And among those, one is OTC.

Okay. Thank you.

Thank you. Just a reminder, it is star followed by one to ask a question. We currently have no further questions, so I'll hand back to Anna for closing remarks.

Thank you, Operator, and thank you all for calling in. The recordings of this call will be published on our webpage shortly. Thank you, everyone, and have a good day.

This concludes today's call. Thank you for joining. You may now disconnect your lines.